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Prior Authorization Protocol
STIVARGAR (regorafenib)

NATL
Coverage of drugs is first determined by the memberís pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • For the treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy.
    • For the treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate.
  2. Health Net Approved Indications and Usage Guidelines:
    • Patient has a diagnosis of metastatic colorectal cancer
    AND
    • Failure or clinically significant adverse effects to fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy (e.g., FOLFOX, FOLFIRI) and an anti-VEGF therapy (e.g., AvastinR, ZaltrapR)
    AND
    • If tumor expresses the KRAS wild type gene, failure or clinically significant adverse effects to an anti-EGFR therapy (e.g., ErbituxR, VectibixR)

    OR

    • Patient has a diagnosis of locally advanced, unresectable or metastatic gastrointestinal stromal tumor

    AND

    • Failure or clinically significant adverse effects to GleevecR and SutentR
  3. Coverage is Not Authorized For:
    • Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.
  4. General Information:
    • Avastin and Zaltrap are anti-VEGF therapies approved for CRC.
    • Erbitux and Vectibix are anti-EGFR therapies approved for CRC.
    • Tumors that have a mutation in the codon 12 or codon 13 of the KRAS gene are essentially insensitive to EGFR inhibitors such as Erbitux or Vectibix. Patients with this mutation should not be treated with EGFR inhibitors either alone or in combination with other anticancer agents, as there is virtually no chance of benefit and unnecessary exposure to increased toxicity.
    • 5-fluorouracil (5-FU) and Xeloda are examples of fluoropyrimidine chemotherapeutic agents
    • A phase II trial of Stivarga for the treatment of renal cell carcinoma has been published.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    AvastinR* (bevacizumab)

    Metastatic colorectal cancer
    5 or 10 mg/kg IV every 14 days in combination with 5-FU based chemotherapy

    20 mg/kg

    irinotecan* (CamptosarTM)

    Metastatic colorectal cancer
    125 mg/m2 IV in combination with 5-FU based chemotherapy

    350 mg/m2

    oxaliplatin (EloxatinR)

    Metastatic colorectal cancer
    85 mg/m2 IV in combination with 5-FU based chemotherapy

    130 mg/m2

    ErbituxR* (cetuximab)

    Metastatic colorectal cancer
    400 mg/m2 IV for initial dose, then weekly infusions of 250 mg/m2 IV

    400 mg/m2

    5 FU (fluorouracil)

    Metastatic colorectal cancer
    400 mg/m2 IV on day 1, 1200 mg/m2 for 2 days

    2400 mg/m2

    VectibixR* (panitumumab)

    Metastatic colorectal cancer
    6 mg/kg IV every 2 weeks

    9 mg/kg every 3 weeks

    ZaltrapR* (ziv-aflibercept)

    Metastatic colorectal cancer
    4 mg/kg IV every 2 weeks plus FOLFIRI regimen (irinotecan, leucovorin, 5-FU)

    4 mg/kg

    FOLFOX = Infusional 5-FU/leucovorin(LV) /EloxatinTM (oxaliplatin)

    Metastatic colorectal cancer
    Eloxatin (oxaliplatin) 85 mg/m2 IV over 2 hours day 1; leucovorin 200 mg/m2 IV over 2 hours day 1 & 2,
    followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes,
    followed by 600 mg/m2 IV 5-FU continuous infusion over 22 hours on day 1 & 2.
    Repeat cycle every 14 days

    Varies upon protocol and patient tolerance

    FOLFIRI = Infusional 5-FU/leucovorin/Camptosar (irinotecan)

    Metastatic colorectal cancer
    Camptosar (irinotecan) 180 mg/m2 IV over 90 minutes day 1;
    Leucovorin 400 mg/m2 IV over 2 hours day 1 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes,
    followed by 2.4-3 gm/m2 IV 5-FU continuous infusion over 46 hours.
    Repeat cycle every 14 days

    Varies upon protocol and patient tolerance

    capecitabine (XelodaR)

    Metastatic colorectal cancer
    1,250 mg/m2 PO BID days 1-14.
    Repeat every 21 days for 8 cycles.

    Varies upon protocol and patient tolerance

    GleevecR (imatinib)

    Gastrointestinal stromal tumor
    400 mg PO QD up to 400 mg PO BID

    800 mg/day
    SutentR (sunitinib)
    Gastrointestinal stromal tumor
    50 mg PO QD for 4 weeks followed by 2 weeks off
    87.5 mg/day

    CapeOx =

    Metastaic colorectal cancer
    Eloxatin (oxaliplatin) 130mg/m2 IV over 2 hours day 1; Xeloda. (capecitabine) 1000mg/m2 PO BID days 1-14 every 3 weeks for 24 weeks

    Varies upon protocol and patient tolerance

    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Stivarga

    160 mg PO QD for the first 21 days of each 28-day cycle

    Treatment continues until no longer clinically beneficial or until unacceptable toxicity occurs.

    Length of Benefit
  7. Product Availability:
    Tablets: 40 mg
  8. References:
    1. Stivarga [Prescribing Information] New York, NY: Pfizer Pharmaceuticals; May 2013.
    2. National Comprehensive Cancer Network. Colon Cancer Version 3.2014. Available at http://www.nccn.org. Accessed July 1, 2014.
    3. National Comprehensive Cancer Network. Rectal Cancer Version 3.2013. Available at http://www.nccn.org. Accessed November 6, 2012.
    4. National Comprehensive Cancer Network. Soft Tissue Sarcoma: Gastrointestinal Stromal Tumors (GIST) Version 2.2014. Available at http://www.nccn.org. Accessed July 1, 2014.
The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.